Study of Oral High/Low-dose Cepharanthine Compared With Placebo in Non Hospitalized Adults With COVID-19
- Registration Number
- NCT05398705
- Lead Sponsor
- Shanghai Jiao Tong University School of Medicine
- Brief Summary
The purpose of this study is to evaluate the efficacy and safety of high/low-dose cepharanthine for the Treatment of COVID-19 in asymptomatic and non-pneumonia mild adult participants with COVID-19 who do not need to be in the hospital, but in alternate care site.
- Detailed Description
Screening participants will sign the appropriate informed consent form (ICF) prior to completion of any study procedures.
Patients will be randomized to one of three arms, all participants will receive standardized medical treatment (SMT) according to Scheme for Diagnosis and Treatment of 2019 Novel Coronavirus Pneumonia (The 9th Trial Edition) from health commission of China, including bed rest, adequate energy and nutrition, pay attention to water and electrolyte balance to maintain a stable internal environment, closely monitor and Chinese traditional medicine, etc.
* low-dose experimental arm：cepharanthine 60mg/day + SMT
* high-dose experimental arm：cepharanthine 120mg/day + SMT
* placebo control arm：placebo + SMT
The primary outcome measure is the time to viral clearance which defined as first positive nucleic acid test to the date of the first negative test (in two consecutive point). SARS-CoV-2 viral load was detected and quantified by RT-PCR using nasopharyngeal swabs . Ct value\>35 for both ORF1ab and N gene was considered as negativity.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 450
- aged over 16 years old with all genders
- SARS-CoV-2 positive（laboratory-confirmed reverse transcription polymerase chain reaction (RT PCR) test)
- patient or immediate adult family member agrees to participate in this study and signs an informed consent form
- asymptomatic or patients with mild covid-19 symptoms
- confirmed SARS-CoV-2 infection within 5 days prior to randomization
- Confirmed SARS-CoV-2 infection within > 5 days prior to randomization
- CT shows pneumonia on admission
- diagnosed as severe or critical COVID-19 before intervention
- has a history of chronic underlying disease and acute exacerbation of that underlying disease at the time of admission
- Females who are pregnant or breastfeeding
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Low-dose cepharanthine + standardized medical treatment Cepharanthine Drug: cepharanthine (tablet) Day 1\~5: 20mg, Q8H X 5 days + standardized medical treatment High-dose cepharanthine + standardized medical treatment Cepharanthine Drug: cepharanthine (tablet) Day 1\~5: 40mg, Q8H X 5 days + standardized medical treatment placebo+standardized medical treatment Placebo Drug: cepharanthine placebo (tablet) Day 1\~5: placebo + standardized medical treatment
- Primary Outcome Measures
Name Time Method Time to viral clearance Day 1 through Day 28 The time to viral clearance was defined as first positive nucleic acid test（or randomization） to the date of the first negative test (in two consecutive point)
SARS-CoV-2 viral load Day 1 through Day 28 SARS-CoV-2 viral load was detected and quantified by RT-PCR using nasopharyngeal swabs . Ct value\>35 for both ORF1ab and N gene was considered as negativity.
- Secondary Outcome Measures
Name Time Method Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)of CEP relative to placebo. Day 1 through Day 28 Proportion of participants developing COVID-19 pneumonia Day 1 through Day 28 Proportion of participants developing severe pneumonia Day 1 through Day 28 Number of days from the onset of fever until the temperature drops below 37.3°C Day 1 through Day 28
Trial Locations
- Locations (2)
Xinhua Hospital Affiliated To Shanghai Jiao Tong University School Of Medicine
🇨🇳Shanghai, Shanghai, China
Ren Ji Hospital, School of Medicine, Shanghai Jiao TongUniversity
🇨🇳Shanghai, Shanghai, China